Scimed, plymouth, mn, usa and consists of an elliptical, nickelplated, brass burr figure 5 which is coated with 2,0003,000. Rotational atherectomy was performed using the rotablator boston scientific, fremont, california, usa and conventional techniques. A novel rotablator technique lowspeed following highspeed. Jun 16, 2015 the boston scientific pathway jetstream atherectomy system is a singleuse catheter with a reusable, compact console power source and a frontcutting tip that allows it to go through severely stenotic lesions without predilation. This device has a burr on the end of it and rotates at high speed around a guidewire. Boston scientific to reintroduce rotablator devices. We have used this device in both aboveknee and belowknee cases that are described in this article. The jetstream atherectomy system by boston scientific is the only atherectomy system with active aspiration, designed to treat mixed morphology, such as calcium, plaque and thrombus.
These guidewires, designed exclusively for the rotablator rotational atherectomy system, can be independently advanced and steered. System boston scientific corporation figure 1 is one of the newer additions to the peripheral atherectomy device field. Rotablator system reference guide boston scientific. The rotablator system features a full family of products. Boston scientific recommends that you consult with your payers, reimbursement specialists andor legal counsel regarding coding, coverage and reimbursement matters. In general, the risk of burr entrapment or vessel perforation is greater in an angulated calcified lesion compared with a straight calcified lesion. Incidence and determinants of complications in rotational. After initial adoption, the enthusiasm for ra was tempered after reports of high restenosis rates in the predes era. The primary function of the atherectomy is to mechanically remove the plaque. The aim of this retrospective, multicenter observational study was to investigate interventional outcomes of a highspeed rotational atherectomy device rotablator and to compare clinical outcomes in patients who underwent rotablator and those who did not even after failed.
Rotablator boston scientific sirolimuseluting orsiro stent biotronik independent clinical event committee chair. Intracoronary verapamil was administered during rotablation. The rotablator rotational atherectomy system is intended for percutaneous use in the peripheral vessels. This is a procedure which attempts to bore out a narrowing in a coronary artery which might not otherwise respond to stenting. The rotablator rotational atherectomy system figure 1.
Tuesday, september 4th 2018 from 12pm to 02pm gmt london dublin. Sakakura has received speaking honoraria from abbott vascular, boston scientific, medtronic cardiovascular, terumo, orbusneich, japan lifeline and nipro. Ra produces lumen enlargement by physical removal of plaque and reduction in plaque rigidity, facilitating dilation. The coronary rotablator atherectomy system has been used for the last 20 years, and it has been very successful in treating moderate and severe calcific coronary. Atherectomy can be used independently or in conjunction with pci or stent deployment. Rotablation speed ranged between 140,000 and 180,000 rotations per minute. Rotablator rotational atherectomy system boston scientific. Peripheral rotablator rotational atherectomy system. Product setup videos, guides and checklists boston. Mar 03, 2002 the manufacturer, scimed boston scientific, maple grove, mn recommends the following guidelines when selecting the french size of the guide. Rotablator rotational atherectomy system diamondtipped burr designed to immediately engage the lesion to facilitate safe ablation. Rotational atherectomy and mechanical support to treat. The rotablator system boston scientific, natick, ma consists of a nickelcoated brass burr fig.
Bsx recalled nearly 1,000 components used with its rotablator atherectomy device after receiving 3 reports that the catheters guidewire fractured during procedures to. The catheter is moved up the inside of the artery until it reaches the. Then a 5 x 220mmlong sterling balloon boston scientific corporation was used for lowpressure angioplasty of 4 atm, for a total of 3 minutes. Boston scientific does not promote the use of its products outside their fdaapproved label. Rotablator rotational atherectomy system prep youtube. Rotational atherectomy is employed by several devices, one being the rotablator rotational atherectomy system by boston scientific natick, ma. Boston scientific recalls atherectomy components massdevice. Nov 18, 2019 the commercially available rotablator boston scientific was first introduced by david auth and colleagues in 1988.
Jan 22, 2019 the luminal gain matches the size of the tip. It is the belief of many physicians that the selective tissue ablation effect of the rotablator is the best choice for calcified coronary lesions. A case of entrapped rotablator burr and possible mechanism of. Tuesday, september 4th 2018 from 02am to 04am gmt10 san francisco. The boston scientificpathway jetstream atherectomy system is a singleuse catheter with a reusable, compact console power source and a frontcutting tip that allows it to go through severely stenotic lesions without predilation. The rotablator rotational atherectomy system is a catheterbased angioplasty device utilizing a diamondcoated elliptical burr at the tip of a flexible drive shaft. Guidelinerfacilitated rotational atherectomy in calcified. Boston scientific does not promote the use of its products outside their fda approved label. The rotablator system is controlled using a console, with activation by a foot pedal.
The rotablator system console regulates the flow of air to the advancer, controlling burr rotation speed. A new addition to the group of approved atherec tomy devices is the peripheral rotablator rotational. Tuesday, september 4th 2018 from 08am to 10am gmt4 buenos aires. Do not allow the burr to remain in one location while rotating at high speeds, as this may lead to wear of the guidewire for instance, the burr may cut the. Pdf european expert consensus on rotational atherectomy. Rotational atherectomy rotablator, boston scientific features a nickelplated brass burr coated with microscopic diamond crystals, which spins extremely fast, between 140,000 and 190,000 rpm. Successful retrieval of an entrapped rotablator burr by. We describe a complex percutaneous coronary intervention using rotational atherectomy rotablator, boston scientific, marlborough, massachusetts and mechanical circulatory support impella, abiomed, danvers, massachusetts in a patient with multiple comorbidities scheduled to undergo a left main coronary percutaneous coronary intervention using a 2stent technique based on angiography. Rotablation in the treatment of highrisk patients with. Aug 26, 2016 the rex medical revolution rotational atherectomy system incorporates continuous aspiration and has a dual indication for atherectomy and thrombectomy.
A novel rotablator technique lowspeed following high. A setting of 170,000 to 180,000 rpm was used for a total of 5 minutes. A case of entrapped rotablator burr and possible mechanism. However, we were initially unable to cross the stenosis with the rotating 1. Predilatation of the artery may be required for passage of the tec. The dfu details instructions on the proper set up of the rotablator system. H802 22782001a 0 rotablator rotalink advancer separate from catheter and burr h802 22768002 0 rotalink exchangeable burr catheter 1. A case of entrapped rotablator burr and possible mechanism 003 of entrapment. Effects of highspeed rotational atherectomy in peripheral.
Effect of rotablator on balloon resistant calcified coronary. Tuesday, september 4th 2018 from 08am to 10am gmt4. Flextome cutting balloon boston scientific angiosculpt scoring balloon biotronik scoreflex scoring balloon orbusneich medical rotablator boston scientific sirolimuseluting orsiro stent biotronik independent clinical event committee chair. The peripheral rotablator rotational atherectomy system boston scientific corporation figure 1 is one of the newer additions to the peripheral atherectomy device field. Tuesday, september 4th 2018 from 09am to 11am gmt3 reykjavik. The rotablator system was developed by david c auth, phd boston scientific corporation, redmond, wa, usa and first used in 1988. Halfway rotational atherectomy for calcified lesions. The primary purpose for the development of the rotablator was to tackle the rockhard, calcified lesions that standard angioplasty balloons have failed to effectively treat.
Address calcium ead on sponsored by boston scientific corporation a great benefit of the rotablator atherectomy systems design is the frontcutting diamond burr figure1. It also monitors and displays burr rotation speed and rotational atherectomy procedural time. Ferenc, bad krozingen, germany independent qca core lab isar research center, munich, germany independent statistical core lab derek robinson, sussex, uk. The commercially available rotablator boston scientific, natick, massachusetts, invented by auth and described by ritchie and colleagues, ablates plaque using a diamondencrusted elliptical burr, rotated at high speeds 140,000 to 180,000 rpm by a helical. Strategies for effective treatment of pad in the era of drugcoated balloons and contemporary stenting. This had been used in coronary atherectomy for some time and has an indication in the periphery as well. The rotablator burr is trapped at the distal portion just beyond the angled, severely calcified lesion. The rotablator rotational atherectomy system boston scientific corporation, natick, ma, usa was used for this experiment. Rotablator rotational atherectomy system meditek systems. Ferenc, bad krozingen, germany independent qca core lab isar research center, munich. Percutaneous rotational coronary angioplasty with the rotablator rotational atherectomy system, as a sole therapy or with. Calcified lesions still remain a technical challenge even in the treatment of infrainguinal artery disease.
Some of the devices are equipped with additional cutting blades to maximise debulking. Rotablation cocktail with verapamil, nitrates and heparin in saline 5 mg5 mg5,000 u in 500 ml of saline1. Rotablator console instructions for use oct 2002 pdf download. Rotablator console and foot pedal effective tools for treating calcified lesions without the right device, treating calcified lesions can be challenging. Rotablator system components console, foot pedal and advancer. Rotational atherectomy is employed by several devices, one being the rotablator rotational atherectomy system by boston scientificnatick, ma. Multiple sessions of ablation were unsuccessful in crossing the lesion, even though the device speed was increased to 220,000 rpm. Case report a 69yearold male with coronary artery disease, prior left anterior descending artery lad stenting, ischemic cardiomyopathy, hypertension, diabetes.
The test involves the insertion of a long thin catheter into an artery in the groin or wrist under local anaesthetic. Rotational atherectomy in a patient with acute stelevation. It is currently available as rotablator system boston scientific corporation. Emblem sicd system patient guide boston scientific. A new addition to the group of approved atherectomy devices is the peripheral rotablator rotational atherectomy system boston scientific corporation, natick, ma. Natick, ma plans to reintroduce the original rotablator rotational atherectomy device in limited supply later this month. Rotablator procedure cardiology procedures sa heart. Ra was carried out using the rotablator ra system boston scientific corporation, starting with a 1.
The interest in rotational atherectomy ra is growing in the current percutaneous coronary intervention pci, mainly because of the expansion of pci indications to more complex atherosclerotic lesions as a consequence of the improved restenosis rate after drugeluting stent evolution. We used a left femoral access, a long sheath, and an amplatz left 1 guide catheter boston scientific, natick, massachusetts to optimize support. The rotablator system components include the console, foot pedal, and rotalink plus advancer and burr. Rotablator rotational atherectomy system prep boston scientific cardiology. Highspeed rotational atherectomy before paclitaxel. While rotating on the rotawire boston scientific corporation, this frontend cutting feature. It is the only atherectomy device to offer continuous aspiration and active removal of atherosclerotic debris and.
Rotational atherectomy and mechanical support to treat left. The burr size was selected to reach a burrvessel ratio of 0. Jun 19, 2018 percutaneous coronary interventions pci of old calcified saphenous vein grafts svgs is challenging and is associated with a considerably high risk of adverse ischemic events in the short and longterm as compared to native coronary arteries. Boston scientific corporation 300 boston scientific way marlborough, ma 01752. An innovative retrieval technique for an entrapped. Rotational atherectomy an overview sciencedirect topics. Effective debulking with the jetstream atherectomy system. At this stage, there was reocclusion of rca and the stelevation started to worsen.
The standard in rotational atherectomy, the rotablator system provides an excellent option for treating calcified lesions, with a complete family of products. Field repair, other than the consoles external fuse replacement, voids all warranties and may not be performed without express authorization. The systems currently available for rotational atherectomy are the rotarex s system straub medical, the jetstream atherectomy device boston scientific and the peripheral rotablator system boston scientific. Early experience with peripheral rotablator atherectomy. A cocktail consisting of rotaglide lubricant boston scientific corporation, verapamil, nitroglycerin, and heparin can be infused during ablation to reduce vasospasm. The rotawire was placed into the tibial vessels, and rotablator atherectomy was performed using a 2. Rotablator using 140, 160, 000 rpm, small rota burr burrtoartery ratio, 0. Boston scientific, natick, ma has been commercially available for use in the coronary arteries for the past 3 decades. All other service must be performed by boston scientific corporation. Many interventional cardiologists choose the rotablator rotational atherectomy system an essential tool from boston scientific. Tuesday, september 4th 2018 from 05am to 07am gmt7 new york. Under fluoroscopic guidance, an appropriatesized introducer catheter is placed, and a guidewire is passed through the lesion. Cardiac interventions today issn 25725955 print and issn 25725963 online is a publication dedicated to providing coverage of the latest developments in technology, techniques, clinical studies, and regulatory and reimbursement issues in the field of coronary and cardiac interventions.
We describe a complex percutaneous coronary intervention using rotational atherectomy rotablator, boston scientific, marlborough, massachusetts and mechanical circulatory support impella, abiomed, danvers, massachusetts in a patient with multiple comorbidities scheduled to undergo a left main coronary percutaneous coronary intervention using a 2stent technique based. The company will continue to ramp up the manufacture of the device and expects to have more significant quantities available in the fourth quarter. The commercially available rotablator boston scientific, natick, massachusetts, invented by auth and described by ritchie and colleagues, ablates plaque using a diamondencrusted elliptical burr, rotated at high speeds 140,000 to 180,000 rpm by a helical driveshaft, that advances gradually across a lesion over a guidewire. All subjects were given 100 mgday aspirin and clopidogrel 300 mg loading dose and 75 mgday maintenance dosage at least 24 h before the procedure. Rotablation was performed by the rotablator boston scientific scimed, maple grove, minnesota. Effect of rotablator on balloon resistant calcified. The rotawire may be spinning in rotational atherectomy. Atherectomy with the tec is primarily performed percutaneously but can also be used adjunctively with open surgery. Successful removal of stuck rotablator burr iyad azzam. Conventional intervention will be performed in the rotablator group. May 09, 2012 rotablator rotational atherectomy system prep boston scientific cardiology. Bench test results may not necessarily be indicative of clinical performance. An entrapped rotational atherectomy burr is uncommon, but one of the nightmare complications in the cardiac cath lab.
604 831 267 96 1383 200 10 767 22 718 1031 1333 1370 1329 510 1131 485 523 575 1194 1494 456 997 1415 55 473 1420 587 156